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The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.

50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.

The document describes the acceptance criteria and performance of the Disposable Medical Mask (Model: RYSM001) manufactured by Yangzhou Runyi Arts & Crafts CO., LTD. It is a 510(k) summary demonstrating substantial equivalence to a predicate device (Single-use Medical Face Mask, K203591 from Conod Medical Co., Limited).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flame Spread):
  • Sample Size: 3 non-consecutive lots, with 32 samples per lot.
  • Data Provenance: The tests were conducted internally by the manufacturer or a contracted testing facility as part of the premarket notification (K203112) for the proposed device (Disposable Medical Mask, RYSM001). The data comes from non-clinical bench testing. The country of origin for the data is implicitly China, given the manufacturer's address. It is retrospective data collected for submission.
• For Biocompatibility tests (Cytotoxicity, Sensitization, Irritation):
  • The document implies that these tests were conducted on the proposed device to meet the ISO 10993 standards, indicating testing of the device materials. Specific sample sizes for these tests are not provided in the summary but are generally conducted on material extracts or actual device materials according to the standard.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document describes non-clinical, bench-top performance and biocompatibility testing of a medical mask. It does not involve human expert adjudication or ground truth establishment in the way this question typically refers to it (e.g., for AI/image analysis studies). The "ground truth" for these tests are the established standards and their predefined pass/fail criteria, as determined by the scientific community and regulatory bodies. Therefore, no human experts were used to establish ground truth for this device in the context of the provided document.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical bench testing against established performance standards, there is no human adjudication or consensus method like 2+1 or 3+1. The results are quantitative measurements compared against predefined thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This document pertains to the 510(k) submission for a physical medical device (mask) based on non-clinical performance and biocompatibility testing. It specifically states "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on established international and national standards for medical face masks and biocompatibility:

• Performance Standards: ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36945C, 16 CFR 1610. These standards define the test methodologies and the acceptance criteria (e.g., minimum filtration efficiency, maximum differential pressure, specified fluid resistance).
• Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). These standards provide protocols for evaluating the biological response to medical devices and define acceptable limits for these biological effects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product validated through bench testing.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth to be established for it.

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